Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation Recalled by Xcision Medical Systems, LLC Due to Wrong structures imported into the GammaPod Treatment Planning...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xcision Medical Systems, LLC directly.
Affected Products
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Quantity: 4 units
Why Was This Recalled?
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Xcision Medical Systems, LLC
Xcision Medical Systems, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report